EP0928168B1 - Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration - Google Patents

Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration Download PDF

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Publication number
EP0928168B1
EP0928168B1 EP97936390A EP97936390A EP0928168B1 EP 0928168 B1 EP0928168 B1 EP 0928168B1 EP 97936390 A EP97936390 A EP 97936390A EP 97936390 A EP97936390 A EP 97936390A EP 0928168 B1 EP0928168 B1 EP 0928168B1
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EP
European Patent Office
Prior art keywords
protective
apertures
membrane
bone
bone regeneration
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP97936390A
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German (de)
English (en)
French (fr)
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EP0928168A1 (en
Inventor
Stefan M. Lemperle
Christopher J. Calhoun
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MacroPore Inc
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MacroPore Inc
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30428—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by inserting a protrusion into a slot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30785—Plurality of holes parallel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30787—Plurality of holes inclined obliquely with respect to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • A61F2002/4649—Bone graft or bone dowel harvest sites
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors

Definitions

  • the present invention relates generally to implants for use in repairing various portions of the mammalian skeletal system and, more particularly, to implants for use in clinical procedures such as bone fracture repair, regeneration of bone loss, augmentation of deficient bone, and related procedures.
  • defects in the mammalian skeletal system can be treated by various surgical procedures.
  • Defects in the mammalian skeletal system may include bone fracture, loss of bone occurring from traumatic, surgical, or infectious sources, and bone deficiencies stemming from conditions such as atrophy and congenital anomalies.
  • a typical cell-occlusive, fluid permeable membrane 10 is illustrated surrounding a first section of the long bone 12 and a second section of long bone 14.
  • the bone defect area 20 is bounded by the two ends 16, 18 of the first section of long bone 12 and the second section of long bone 14, respectively, and by the cell-occlusive, fluid-permeable membrane 10.
  • this bone defect area 20 can receive blood from the bone vessels 23, blood and cells from the surrounding blood vessels 25 and tissues 27 is precluded from entering the bone defect area 20.
  • the periosteum 31 and the surrounding tissues 27 are just external to the cell-occlusive, fluid-permeable membrane 10 and are guided in the directions of the arrows A1 and A2.
  • US 5,496,372 discloses a hard tissue prostheses including porous thin metal sheets.
  • the prostheses is for the replacement of hard tissues of human bones and joints and comprises a porous lamination component of metal thin sheets, each having a plurality of through holes and a thickness of 150 ⁇ m or less, and being unharmfull to the living body, the porous lamination component being formed such that the sheets are laid over one another and are then diffusion bonded there between into one body.
  • EP 0 475 077 A2 pertains to a bone regeneration membrane.
  • the bone regeneration membrane contains resorbable or degradable, polymeric and/or polymeric ceramic material.
  • the membrane can be used for the spontaneous regeneration of bone and for the improved application of autologous and allogenic graft materials and therapeutic agents.
  • the object of the present invention is to provide a protective bone regeneration membrane for protecting a hard tissue defect from a prolapse of adjacent soft tissues.
  • a protective bone regeneration membrane 42 comprising a base material 44 and apertures 46.
  • the protective bone regeneration membrane 42 is shown in Figure 2 wrapped around a bone defect area 49.
  • the bone which is surrounded by the protective bone regeneration membrane 42, comprises a first section of long bone 51, a second section of long bone 53, and a partially healed intermediate section of long bone 55.
  • the protective bone regeneration membrane 42 is rigid enough to prevent prolapse of the surrounding tissues 57 into the bone defect area 49.
  • the apertures 46 of the protective bone regeneration membrane 42 are large enough to allow for a proliferation of cells (not shown) and blood vessels 61 therethrough and into the first section of long bone 51, the second section of long bone 53, and the partially healed bone defect area 49. Since the protective bone regeneration membrane 42 of the presently preferred embodiment is rigid enough to withstand prolapse of the surrounding tissue 57, the regeneration of the partially damaged periosteum 64 is guided over the protective bone regeneration membrane 42 in a direction substantially parallel to the arrows A3 and A4.
  • the apertures 46 within the protective bone regeneration membrane 42 are both cell and fluid permeable, and the base material 44 of the protective bone regeneration membrane 42 is rigid enough to maintain the available space between the first section of long bone 51 and the second section of long bone 53 for ideal bone regeneration. Additionally, the base material 44 is resorbable, according to the presently preferred embodiment.
  • the cell-occlusive membrane of the prior art membrane 10 ( Figure 1), in contrast, is specifically designed to prevent the proliferation of cells and vessels therethrough. This membrane 10 is also insufficiently rigid and non-resorbable.
  • Figures 3a and 3b illustrate different embodiments of a sheet of the protective bone regeneration membrane 42, comprising the base material 44 and the apertures 46.
  • the protective bone regeneration membrane 42 comprises either a biodegradable synthetic material or a biodegradable natural material, or both.
  • the biodegradable synthetic material may comprise polymers, for example, and the biodegradable natural material may comprise collagen, for example.
  • Each of the apertures 46 preferably has a diameter within a range of between 20 microns and 3000 microns. In the presently preferred embodiment, each aperture 46 comprises a diameter of approximately 1500 microns.
  • a thickness of the base material 44 is preferably within a range between 100 microns and 2000 microns, but may also be configured as thin as 10 microns.
  • the pattern of distribution of the apertures 46 may vary according to the bone defect being treated.
  • the ranges of aperture 46 sizes, base material 44 thickness, and aperture 46 shape and distribution is preferably implemented by the present invention in order to optimize the protective bone regeneration membrane 42 to different environmental conditions.
  • Examples of the different environmental conditions encountered in different bone defects include the location of the defect (long bone or flat bone), the type of defect (discontinuity defect, contour defect, window defect, trephine defect), size of the defect, the presence or absence of periosteum 64, and the general condition of the adjacent soft tissues covering the bone defect.
  • Figure 4 illustrates the protective bone regeneration membrane 42 applied to a long bone 68 of a patient.
  • the protective bone regeneration membrane 42 is applied to the long bone 68 in combination with a fixation device 70.
  • the fixation device 70 can be secured to the long bone 68 using conventional means, such as screws 72.
  • tacks may be used in place of or in combination with the screws 72.
  • fixation device 70, the screws 72, and the protective bone regeneration membrane 42 together securely hold the first section 75 of the long bone 68 to the second section 77 of long bone 68.
  • a bone defect area 79 is protected against the prolapse of adjacent soft tissues, for example, by the protective bone regeneration membrane 42.
  • the prior art titanium screen mesh is designed to remain permanently attached to the bone, resulting in long-term stress shielding and resorption of newly formed bone within the bone defect area 79.
  • the protective bone regeneration membrane 42 of the present invention is preferably configured of a resorbable, bio-compatible material.
  • the protective bone regeneration membrane 42 of the presently preferred embodiment will have resorbed sufficiently to no longer shield stress from the bone defect area 79 to thereby encourage an increase of bone formation.
  • the fixation device 70, and/or the screws 72 are also formed of a resorbable material. That is, the combination of the fixation device 70, the screws 72, and the protective bone regeneration membrane 42 prevent excessive motion between the first section 75 and the second section 77 of the long bone 68.
  • this period of time sufficient for complete new bone regeneration within the bone defect area 79 is between approximately 2 to 24 months.
  • the resorption of the protective bone regeneration membrane 42 to a point where the protective bone regeneration membrane 42 can no longer shield significant mechanical stress on the first section 75 and the second section 77 is between approximately 2 and 24 months.
  • the protective bone regeneration membrane 42 may comprise a non-resorbable material.
  • the protective bone regeneration membrane 42 is non-resorbable and the fixation device 70 is resorbable, resorption of newly formed bone within the bone defect area 79 is still prevented.
  • the protective bone regeneration membrane 42 is configured to be flexible enough to prevent stress shielding between the first section 75 and the second section 77, after the fixation device 70 has been resorbed to a point where the fixation device 70 no longer exerts mechanical strength on the first section 75 and the second section 77 of the long bone 68.
  • the protective bone regeneration membrane 42 of the present invention is designed to be used in combination with a fixation device 70, in a preferred embodiment, while the titanium screen mesh of the prior art comprises a fixation device designed predominantly to be used alone.
  • the protective bone regeneration membrane 42 of the present invention may be used in combination with the prior art titanium screen mesh, as well as in combination with any other conventional fixation device.
  • internal fixation devices can be divided into two classes. Cortical compression plates comprise a first class and intramedullary rods comprise a second class. Both classes of devices are unable to secure and stabilize shattered bone, because bone fragments are often small and free floating within the fracture cavity.
  • the protective bone regeneration membrane 42 of the presently preferred embodiment is preferably resorbed within the body of the patient to a point where substantial mechanical fixation is no longer exerted on the first section 75 and the second section 77 of the long bone 68, within a period of approximately 1 year. Complete resorption of the protective bone regeneration membrane 42 may subsequently occur after a total period of 11/2 to 2 years have elapsed since the initial implantation.
  • the protective bone regeneration membrane 42 of the present invention is resorbed into the body of the patient. Allogenic bone grafts are only partially substituted with new bone over time, typically comprising 1 to 2 years, forming a permanent composite of viable (new) bone and non-viable cadaver bone.
  • allogenic bone grafts cannot achieve a complete regeneration of the entire bone defect with new living bone, as can the protective bone regeneration membrane 42 of the present invention.
  • This benefit is achieved by placement of the protective bone regeneration membrane 42 outside of the bone defect area 49, rather than within the bone defect area 49.
  • the holes within the allogenic bone graft of the prior art are substantially occluded by induced bone formation therein within approximately 2 to 3 weeks after the initial implantation.
  • the protective bone regeneration membrane 42 of the present invention is designed to be placed completely outside of the bone defect area, in order to maintain a maximal size of the bone defect area 79 for regeneration of new bone by the patient in the area 79.
  • allogenic bone grafts are inferior to the protective bone regeneration membrane 42 of the present invention in providing a combination of patient safety in preventing disease transmission, optimal prolapse prevention and maximal space preservation for bone regeneration, and vasculature ingrowth potential.
  • the above-mentioned skin graft of the prior art comprises apertures which are quickly occluded by the ingrowth of epithelial cells therein. These prior art apertures, similarly to the allogenic bone graft holes, are actually filled with the desired tissues, whereas, the apertures of the protective bone regeneration membrane 42 allow ongoing transmigration of cells and blood vessels for generating the desired tissue.
  • these apertures are formed having a diameter of approximately 1 millimeter, whereas the preferred diameter of the apertures of the present invention are approximately 1.5 millimeters.
  • the skin graft membrane of the prior art is specifically designed for providing an in vitro scaffold and subsequent transplantable skin graft, whereas the present invention preferably operates in vivo.
  • the present invention is directed to maintaining a space, protected against adjacent soft tissue prolapse, to thereby facilitate spontaneous bone regeneration by the patient within the protected space.
  • the present invention recognizes that spontaneous bone regeneration by the patient can be greatly accelerated and enhanced by allowing the infiltration of surrounding blood vessels and cells.
  • mesenchymal stem cells which can be found in surrounding mesodermal tissues, are the precursor cells that eventually form muscle, cartilage, tendons, ligaments, connective tissues, and bone. These cells are present in these tissues and are involved in the perpetual renewal of each specific tissue, although in their earliest stage of development, these cells are not committed to becoming any given tissue. An uncommitted mesenchymal stem cell found in muscle, for example, will not strictly become a muscle cell. If the mesenchymal stem cell is needed to become a bone cell, the mesenchymal stem cell may migrate to a bone defect and differentiate into a bone forming cell.
  • the mechanism for attracting these cells and directing them to become a specific tissue cell is understood by the present inventors to be controlled by morphogenic proteins, although other factors may be involved. In bone, for example, these proteins are commonly referred to as bone morphogenic proteins.
  • the apertures 46 of the protective bone regeneration membrane 42 harness this mechanism, by allowing bone morphogenic proteins derived from within the bone matrix to attract mesenchymal stem cells from the surrounding connective tissues, musculature, periosteum, and vasculature. The attracted elements are then directed to differentiate into bone forming cells, which are essential for new bone formation by the patient.
  • the apertures 46 of the present invention allow vital contributions of blood vessels from surrounding tissues, musculature, and periosteum into the protected area.
  • Blood vessels invading the bone defect through the protective bone regeneration membrane 42 of the present invention greatly enhance the generation of new bone, as compared to prior art cell-occlusive membranes that limit the supply of blood to that coming from within the bone defect itself.
  • the ability for capillaries from surrounding soft tissues to proliferate through the protective bone regeneration membrane 42 helps prevent migrating cells from the osseous bed and the periosteum from outstripping their proliferating blood supply. This proliferation of blood vessels increases the potential of spontaneous bone regeneration within a given defect.
  • mesenchymal stem cells are believed to be perivascular (around blood vessels) connective tissue cells, which would additionally foster bone regeneration by the transmembranous sprouting of capillaries, since most vasculature has associated connective tissues.
  • the base material 44 may be impregnated with a variety of substances for promoting the regeneration of different tissues such as bone and blood vessels.
  • the base material 44 may be impregnated with a chemotactic substance for influencing cell-migration, an inhibitory substance for influencing cell-migration, a mitogenic growth factor for influencing cell proliferation and a growth factor for influencing cell differentiation (e.g. insulinelike growth factor, transforming growth factor-beta, fibroblast growth factor, platelet-derived growth factor), and factors which promote neoangiogenesis (formation of new blood vessels).
  • a chemotactic substance for influencing cell-migration an inhibitory substance for influencing cell-migration
  • a mitogenic growth factor for influencing cell proliferation e.g. insulinelike growth factor, transforming growth factor-beta, fibroblast growth factor, platelet-derived growth factor
  • factors which promote neoangiogenesis formation of new blood vessels.
  • the base material 44 is flexible both at the time of manufacture and after hydration. This flexibility allows the protective bone regeneration membrane 42 to be bent and shaped such that, after the area is completely healed, the contour of the healed bone matches the contour of the original bone, or matches the contour of the original bone as closely as possible.
  • the base material 44 ( Figure 3) further provides an advantageous rigidity, which is higher than other currently used membrane materials ( Figure 1) to thereby provide sufficient strength against soft tissue pressure.
  • the method generally comprises a step of affixing the protective bone regeneration membrane 42 (Figure 3) onto a portion of the mammalian skeletal system in need of repair.
  • the fixation of the protective bone regeneration membrane 42 may be accomplished by any conventional surgical technique, including the use of resorbable pins, screws, and sutures.
  • the protective bone regeneration membrane 42 of the present invention can be implanted into the patient without being affixed to existing bone, such as, for example, in the case of orbital floor reconstruction (Figure 5).
  • Figure 5 illustrates several applications of the protective bone regeneration membrane in the cranio-facial region of a human skull.
  • a protective bone regeneration membrane 80 is applied over the burrholes and the trephination defect of a human skull 82, after a neurosurgical procedure or trauma.
  • protective bone regeneration membranes 84 are placed over orbital floor fractures to prevent entrapment of overlying muscles and nerves therein.
  • Another protective bone regeneration membrane 86 is applied over a defect area in the maxillary sinus, and still another protective bone regeneration membrane 88 is applied over a bone defect area in the maxilla (upper jaw).
  • Another protective bone regeneration membrane 90 is applied over an edentulous bone defect area in the mandible (lower jaw).
  • a protective bone regeneration membrane 80 is illustrated in Figure 6, applied to the pelvis 82 of a human patient, after a bone autograft has been harvested therefrom.
  • the protective bone regeneration membrane 80 protects the bone defect area 84 from soft tissue interposition, while allowing the ingrowth of blood vessels and cells. If necessary, the protective bone regeneration membrane 80 can be affixed onto the adjacent bone using pins, screws, sutures, or other conventional means.
  • Figure 7 illustrates a protective bone regeneration membrane 93 applied around a segmental defect 94 in a human mandible 95, for example.
  • the protective bone regeneration membrane 93 can be implanted using an extra-oral (outside of the mouth) surgical approach.
  • the epithelial lining of the mouth is not broken and the protective membrane is placed beneath the epithelial lining of the mouth (since the bone defect is accessed from an extra-oral area such as below the chin). Therefore the epithelial cells cannot enter the bone defect.
  • the present invention is also intended to apply in intra-oral surgical approaches.
  • the defect may be a discontinuity defect, comminuted, or just missing a part of the bone.
  • the intact parts of the mandible 95 are fixated together by a plate 97 and screws 99, if necessary, and the protective bone regeneration membrane 93 protects the bone defect site from interposition of surrounding soft tissue.
  • the protective bone regeneration membrane 93 holds any free-floating fragments of bone in place and provides additional circumferential stabilization to the bone defect.
  • the protective bone regeneration membrane 93 is malleable to a certain extent, the protective bone regeneration membrane 93 is stiff enough to prevent collapse thereof under the weight of adjacent soft tissues.
  • the protective bone regeneration membrane 93 can be easily cut with scissors and shaped by the hand of a user to adapt three-dimensionally to a bone defect area.
  • Figure 8 illustrates another application of the protective bone regeneration membrane 105 of the present invention, as applied to a bone defect area of a long bone 101.
  • the protective bone regeneration membrane 105 is secured to the long bone 101 using a fixation member 107 and screws 109, and comprises a belt-like tab 111.
  • the belt-like tab 111 is adapted for being fed through a slot 113, which is formed between the fixation member 107 and the long bone 101.
  • the protective bone regeneration membrane 105 is secured to the fixation member 107, and both the protective bone regeneration membrane 105 and the fixation member 107 are resorbable, in order to avoid a second surgery for removal of the devices.
  • Surgical removal of non-resorbable, non-metallic membranes is necessary in the prior art, in order to avoid risk such as bacterial contamination and infection.
  • a user can grip the belt-like tab 111 to securely fasten the protective bone regeneration membrane 105 around the long bone 101.
  • This secure fastening of the protective membrane 105 around the long bone 101 can facilitate the holding of bone fragments in place within the bone defect area, in addition to adding stability to the bone fracture.
  • the screws 109 are tightened into the long bone 101 after the protective bone regeneration membrane 105 is tightened around the long bone 101.
  • the embodiment of Figure 8 is especially advantageous for setting comminuted fractures, having multiple bone fragments, to thereby reduce the risk of bone fragment resorption.
  • the protective bone regeneration membrane 105 can be tightened around the long bone 101, until a desired tension is achieved for holding the native fracture fragments in place.
  • the protective bone regeneration membrane 105 can also be used to prevent the dislocation of bone grafts or bone graft substitutes.
  • the protective bone regeneration membrane 105 may be used without a fixation member 107. If it is necessary to stabilize major bone fragments, the protective bone regeneration membrane 105 may be used in conjunction with other rigid fixation devices, either internal or external.
  • the protective bone regeneration membrane 105 may be used with or without a belt-like tab 111 to form a tube around a bone defect area of a long bone 101. If the tube overlaps both fracture ends of the long bone 101, the tube may provide sufficient structural support, resulting from the strength of the protective bone regeneration membrane 105 and the structural characteristics of the tube, to obviate the need for additional plates, screws, or external fixation devices. Structurally, a tube locates supporting elements in the area of highest stress when loaded in shear, compression, or in bending.
  • the tube configuration is superior to intramedullary rods, which lay at the approximate neutral load axis, or eccentrically placed orthopedic plates, which support only one side of the fracture and which may introduce asymmetrical, non-axial loading on the fracture.
  • a tube configuration will also have superior resistance to column (compression) loading. If the ends and seam of the protective bone regeneration membrane 105 are suitably fixated, the configuration will also be superior in shear strength.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Dispersion Chemistry (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Surgical Instruments (AREA)
EP97936390A 1996-08-19 1997-08-05 Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration Expired - Lifetime EP0928168B1 (en)

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US08/699,673 US5919234A (en) 1996-08-19 1996-08-19 Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration
PCT/US1997/013695 WO1998007384A1 (en) 1996-08-19 1997-08-05 Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration
US7240198P 1998-01-23 1998-01-23
US7520498P 1998-02-18 1998-02-18
US9606998P 1998-08-11 1998-08-11

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WO1999037240A3 (en) 2002-11-14
WO1999037240A9 (en) 2000-07-06
US5919234A (en) 1999-07-06
WO1998007384A1 (en) 1998-02-26
JP2000516511A (ja) 2000-12-12
WO1999037240A2 (en) 1999-07-29
AU3907197A (en) 1998-03-06
AU718801B2 (en) 2000-04-20

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